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Edited Transcript of NERV earnings conference call or presentation 6-May-19 12:30pm GMT

Q1 2019 Minerva Neurosciences Inc Earnings Call

Cambridge May 10, 2019 (Thomson StreetEvents) -- Edited Transcript of Minerva Neurosciences Inc earnings conference call or presentation Monday, May 6, 2019 at 12:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Geoffrey Robin Race

Minerva Neurosciences, Inc. - Executive VP, CFO & Chief Business Officer

* Rémy Luthringer

Minerva Neurosciences, Inc. - Executive Chairman & CEO

* Richard Russell

Minerva Neurosciences, Inc. - President

* William B. Boni

Minerva Neurosciences, Inc. - VP of IR & Corporate Communications

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Conference Call Participants

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* Douglas Royal Buchanan

JMP Securities LLC, Research Division - Associate

* Joel Lawrence Beatty

Citigroup Inc, Research Division - VP & Analyst

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Presentation

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Operator [1]

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Welcome to Minerva Neurosciences First Quarter 2019 Conference Call. (Operator Instructions) This call is being webcast live on the Investors section of Minerva's website at ir.minervaneurosciences.com. As a reminder, this call is being recorded.

I would now like to turn the call over to William Boni, Vice President of Investor Relations and Corporate Communications at Minerva. Please proceed.

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William B. Boni, Minerva Neurosciences, Inc. - VP of IR & Corporate Communications [2]

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Good morning. A press release with the company's first quarter 2019 financial results became available at 7:30 a.m. Eastern time today and can be found on the Investors section of our website. Our quarterly report on Form 10-Q was also filed electronically with the Securities and Exchange Commission this morning and can be found on the SEC's website at www.sec.gov.

Joining me on the call today from Minerva are Dr. Rémy Luthringer, Executive Chairman and Chief Executive Officer; Mr. Rick Russell, President; and Mr. Geoff Race, Executive Vice President, Chief Financial Officer and Chief Business Officer.

Following our prepared remarks, we will open the call for Q&A.

Before we begin, I would like to remind you that today's discussion will include statements about the company's future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors that are more fully detailed under the caption, Risk Factors, in our filings with the SEC including our quarterly report on Form 10-Q for the quarter ended March 31, 2019, filed with the SEC on May 6, 2019.

Any forward-looking statements made on this call speak on as of today's date, Monday, May 6, 2019, and the company disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances that occur after today's call, except as required by law.

I would now like to turn the call over to Rémy Luthringer.

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [3]

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Thank you, Bill, and good morning, everyone. Thanks for joining us today. Minerva has 5 late-stage clinical efficacy trials ongoing with 3 product candidates. These include a Phase III trial with roluperidone, MIN-101, for the treatment of negative symptoms in patients with a diagnosis of schizophrenia; a Phase IIb trial with MIN-117 in patients suffering from major depressive disorders, MDD, with associated anxiety; and 3 Phase IIb trials with seltorexant, MIN-202, for insomnia disorder and MDD.

On today's call, I am going to give an update on progress in each of our programs, beginning with roluperidone. Roluperidone is potentially the first treatment for some negative symptoms of schizophrenia. I am pleased to report that we are currently well advanced in our Phase III study.

As I have explained in the past, special care needs to be taken in the conduct of late-stage clinical trials in psychiatric disorders. This includes careful selection of patients and the engagement of extremely well-trained clinical investigators to evaluate the therapeutic benefit of psychotropic drugs. These factors are especially critical when evaluating the effect of a drug on negative symptoms in patients suffering from schizophrenia primarily because of the need to have a complete understanding of patients' history and the time course of the negative symptoms.

Since the start of the trial, we have applied extremely stringent entry criteria. Recently, we have seen more screening fails than expected, which, on one hand, demonstrates the ongoing quality of protocol compliance by our clinical sites, but on the other hand, has had an impact on expected recruitment. In addition, we are now experiencing increased competition for recruitment of schizophrenic patients in those countries where we are currently conducting our study.

Because of these factors, we now expect completion of enrollment to take place during the second half of 2019. Top line results from the 12-week double-blind portion of the trial are therefore expected to be available in the fourth quarter of 2019.

Also we have revised our time line. I am pleased to report that patient selection today has been good and the investigators we have selected in both the U.S. and Europe are performing very well. We recently completed the opening of additional sites in Moldova, Georgia and Ukraine, and today, I'm pleased to report that 61 sites are participating in our trial and applying the highest standards of quality and expertise.

Briefly, to remind participants on the call, this trial will enroll 501 patients in the U.S. and Europe. Patients are being randomized into 2 active treatment groups: 32 and 64 milligrams of roluperidone and placebo.

The primary endpoint is a change from baseline in negative symptoms using the Positive and Negative Syndrome Scale, PANSS; Marder's Negative Symptoms Factor Score, NSFS, over the 12-week double-blind treatment period. This 12-week treatment period is followed by 40-week open-label extension period during which patients on drug during the double-blind phase will continue receiving the original dose. Patients on placebo will be randomized to receive either 32 milligram or 64 milligrams of active drug.

And prior to conducting our Phase III clinical study, we continue preparatory work for regulatory filing and commercialization, including clinical pharmacology studies and manufacturing registration batches. Later in this call, Rick Russell, Minerva's President, will give details of our commercial preparation activities currently ongoing for roluperidone.

MIN-117 is another potential treatment for patients suffering with MDD and associated anxiety disorders as a monotherapy. To the best of our knowledge, there is no effective monotherapy treatment addressing the unmet need among this group of patients and physicians are often obliged to prescribe concomitant medication such as benzodiazepines to manage patients' anxiety symptoms. Although a good number of patients with MDD also have associated anxiety disorders, recruiting anxio-depressive patients sets a higher bar for recruitment rates compared to recruiting patients with MDD only.

In the ongoing Phase IIb MIN-117 trial, completion of enrollment of approximately 324 patients at clinical sites in the U.S. and Europe is now expected in the third quarter of 2019 with top line results expected to be available in the fourth quarter of 2019.

Briefly, the primary objective of the Phase IIb trial is to evaluate the efficacy of 2 fixed doses of MIN-117, 5-milligram and 2.5-milligram compared with placebo in reducing the symptoms of depressed mood as measured by the change in the Montgomery-Asberg Depression Rating Scale, MADRS, total score over a 6-week treatment period.

Secondary objectives include: first, assessment of the change from baseline in symptoms of anxiety using the Hamilton Anxiety Scale, HAM-A; second, the change in severity of illness using the Clinical Global Impression of Severity Scale, CGI-S; and Clinical Global Impression of Improvement Scale, CGI-I; and third, safety over 6 weeks of treatment.

Approximately 324 patients are expected to be enrolled in this trial at around 40 sites in the U.S. and Europe.

Seltorexant, also known as MIN-202, is our third late-stage clinical product in development with Janssen for both the treatment of insomnia disorder and the adjunctive treatment of MDD. Seltorexant is a specific orexin-2 antagonist, and as such, represents a totally innovative mechanism of action to treat both insomnia and MDD.

MDD is a chronic condition, which patients can suffer over long periods of their lifetime. Currently available treatments help lead to full recovery in some, but others will suffer chronically from residual symptoms. Today, we take care of these residual symptoms by prescribing low doses of antipsychotics. This therapeutic strategy has helped some patients but, unfortunately, also induces known side effects of antipsychotics such as weight gain, sedation and motor impairments.

For these reasons, we believe there is an urgent need for an effective treatment with good efficacy and an improved long-term side effect profile. Previous clinical data generated with seltorexant suggest that we can meet both of these objectives in our Phase IIb program.

Three Phase IIb clinical trials with seltorexant were initiated in late 2017 to expand upon earlier positive clinical data in both indications. Two of these trials are in MDD and one is in insomnia disorder. We have made significant progress in all 3 trials, and today, we are pleased to report that all 3 studies will read out earlier than previously expected.

In the first MDD trial designated as a 2001 trial, patient enrollment has been completed with 287 patients enrolled at clinical sites in the U.S., Europe and Japan. I'm pleased to announce the top line results from this trial are expected in the second quarter of 2019.

Enrollment has also been completed in the insomnia trial, designated as a 2005 trial, with approximately 360 patients enrolled at clinical sites in the U.S., Europe and Japan. Top line results from this trial are also expected in the second quarter of 2019.

Finally, in the second MDD trial, designated as a 2002 trial, patient enrollment has also been completed with 100 patients enrolled at clinical sites in the U.S. Top line results from this 6-month trial are expected to be available in the third quarter of 2019.

I look forward to updating you on these important studies in the near future. I would now like to turn the call over to Rick who will summarize ongoing commercial preparation activities with roluperidone.

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Richard Russell, Minerva Neurosciences, Inc. - President [4]

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Thank you, Rémy. I'll provide a brief update on several key activities related to our plans to commercialize roluperidone, if approved by the FDA, for the treatment of negative symptoms of schizophrenia. We plan to file our tradename application with the agency in the second quarter, and additionally, we're on track to finalize our supply agreements for the U.S. market by midyear.

We recently recruited a senior commercial leader and retained appropriate third-party vendor partners to finalize our launch plans in order to be prepared to fully capitalize on the significant opportunity for roluperidone if and when we are successful in gaining appropriate regulatory approval. We've initiated payer research to assist in defining the value proposition in our access strategy. And we've also retained a medical affairs partner to assist us with our strategy and planning in this important area.

As mentioned previously, we believe the unmet need for effective treatments for negative symptoms in schizophrenia represents a substantial commercial opportunity. Roluperidone, if and when approved by the FDA, could potentially help patients and caregivers who suffer from the impact of this debilitating condition.

With that, I'd like to turn it over to Geoff.

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Geoffrey Robin Race, Minerva Neurosciences, Inc. - Executive VP, CFO & Chief Business Officer [5]

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Thank you, Rick. Earlier this morning, we issued a press release summarizing our operating results for the first quarter ended March 31, 2019. A more detailed discussion of our results may be found in our quarterly report on Form 10-Q filed with the SEC earlier today.

Cash, cash equivalents, restricted cash and marketable securities as of March 31, 2019, were approximately $79.3 million. The company believes that its existing cash, cash equivalents, restricted cash and marketable securities will be sufficient to meet its cash commitments for at least the next 12 months from today and into early 2021 based on our current operating plan. The assumptions upon which this estimate is based are routinely evaluated and may be subject to change.

Research and development expenses were $11.6 million in the first quarter of 2019 compared to $8.4 million in the first quarter of 2018. The increase in R&D expenses primarily reflects higher development expenses for the Phase III clinical trial of roluperidone and the Phase IIb clinical trial of MIN-117. We expect research and development expenses to increase during 2019 as we continue patient enrollment and related support activities for the roluperidone and MIN-117 trials.

General and administrative expenses were $4.7 million in the first quarter of 2019 compared to $4.3 million in the first quarter of 2018. This increase in G&A expenses was primarily due to an increase in noncash stock-based compensation expenses and salary costs from increased staffing to support our precommercial activities.

Net loss was $15.8 million for the first quarter of 2019 or a loss per share of $0.41, basic and diluted, compared to a net loss of $12.4 million for the first quarter of 2018 or a loss per share of $0.32 basic and diluted.

Now I'd like to turn the call back to the operator for any questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from Jason Butler of JMP Securities.

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Douglas Royal Buchanan, JMP Securities LLC, Research Division - Associate [2]

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It's Roy in for Jason. Had a couple on the timeline delays. I guess for the roluperidone Phase III screening failure, you mentioned seeing more failures recently. Have you guys changed any of the screening criteria? Is it possibly due to opening sites and new geographies? Is it just randomness? And then you mentioned greater competition for schizophrenia patients. Are you seeing competition specifically for those with negative symptoms? Or is it just more broadly schizophrenia patients?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [3]

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Thank you so much, Roy, for your questions. So I think the screen failure is very random, yes, and it is true that since a few weeks, we have more screen failure. But again, I mean, this shows really that the eligibility criteria are extremely strict and I think also it is a very encouraging point because, I mean, the PIs and the teams at the clinical sites are definitely doing their job and really trying to bring in the right patients. And as I mentioned during my talk, it's very important or it's of utmost importance for a trial with negative symptoms to have this very, very good knowledge about history and stability of negative symptoms. I think this is really the key of success, yes?

So to your second point, is the screen failure related to additional sites, which have been added? I think again, I mean, you cannot find any logic with the new sites compared to the existing sites. So it's definitely spread all over the different sites and obviously, I mean, we have, since the beginning, a little bit more screen failure in the U.S. as compared to Europe. But definitely, it is not related to the new sites, which have been opened. I mean what we're doing, to be very clear, is each side is retrained before it starts to work and that means recently open sites obviously have been retrained when, I mean, they started to screen, and I mean, even we are assisting them in the way that, I mean, we are available once we have screened the first patient in order to really, how to say, bring them on speed if they have any questions.

Now concerning the competition. I really think that it is competition concerning schizophrenia overall, yes? It's definitely not related to negative symptoms trials. Also, as you know, there are -- there is a trial run by ACADIA as [methadone] study for antipsychotics. And recently, for example, Lundbeck announced that they will start the trial, yes, but I was more referring to the overall activity in the space of schizophrenia where, I mean, the biggest efforts I think are going to more safety, improved treatments for positive symptoms. Clearly, I mean our drug is a leading drug and by having this develop out of sites there recently, our drug is really the drug, which is in the mind of the people doing the trial.

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Douglas Royal Buchanan, JMP Securities LLC, Research Division - Associate [4]

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Okay. Great. That's very helpful. And then maybe can you just remind us what the decision-making process and timing between yourself and JNJ are this quarter based on the results of the trials we expect? And what milestones depend on those?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [5]

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So can you repeat the first part. Sorry, I did not understand.

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Douglas Royal Buchanan, JMP Securities LLC, Research Division - Associate [6]

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Yes. I guess just the timing and the gating events between yourselves and JNJ regarding the seltorexant trials.

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [7]

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Okay. So I will answer the timing and for the gating events, I will give over to Geoff, yes? So I think for the timing, I mean, these 2 studies, I mean, we will have the data before or during the second quarter of 2019, are extremely well recruited. And I mean we really could see very good recruitment all over the duration of the recruiting time. And indeed, I mean the databases have been locked and the data are currently analyzed. So I think you have to stay with us some additional days or weeks in order to make sure that, I mean, things are completely analyzed, that we can really give us the complete top line results we want to give over. But things are really going extremely well here and we are now in the process of analyzing the data.

For the third study, this is a 6-month study. So obviously here, it takes a little bit longer. So the study is recruited. It takes a little bit longer to come up with the top line results. But again, the study is completely recruited. So this is, obviously, extremely good data. As you know, I mean some trials are taking a little bit longer. Other trials are going a little bit faster. Again, I think what is very important is to stay with the right number of sites. Too many sites is bringing a lot of noise into your data. To keep the investigators very motivated, which is technically the case, I mean I can tell you that I have been last week in Ukraine. I have been 2 weeks ago in Bulgaria. They are extremely motivated to continue this trial and to provide the best quality, yes? So that means that this is probably [RS]. So Geoff, maybe you can take the second part of the question.

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Geoffrey Robin Race, Minerva Neurosciences, Inc. - Executive VP, CFO & Chief Business Officer [8]

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Yes, sure. I think the question was that are there any milestones associated with the completion of this study? The answer is no. There are no clinical-linked milestones. And I think there -- to go back to the previous point in terms of the gating issues, as Rémy said, there are currently no gating issues. The trials are fully enrolled and data is being analyzed and we'll publish that when it's available.

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Douglas Royal Buchanan, JMP Securities LLC, Research Division - Associate [9]

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Okay. So there's a Decision Point 4 of $40 million unforeseen to Phase III. Do you expect that probably second half? Is that fair to say?

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Geoffrey Robin Race, Minerva Neurosciences, Inc. - Executive VP, CFO & Chief Business Officer [10]

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I think it's difficult to respond to that question at the moment. We would like to, obviously, complete our review of all of the data before we decide on next steps, which, of course, is the Decision Point 4 that you're referring to and I think it's not possible to give any guidance in terms of when that may occur.

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [11]

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If you allow me just to add, I think, as Geoff said, I mean we need to have all the data in hand, yes, and we need to have the data really from 3 trials. So I think really we need to wait a little bit for the decision.

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Operator [12]

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(Operator Instructions) And our next question comes from Joel Beatty of Citi.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [13]

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The first one is on the seltorexant depression study reading out this quarter. Can you tell us beyond the primary endpoints, what secondary endpoints will be important to consider to get a sense of how differentiated the patient is compared to other agencies for depression?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [14]

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Yes, Joel. This is a great question. First, so definitely obviously, we try to -- the primary endpoint is very clear. I mean it is to show that, overall, in these patients who are responding extremely well to SSRI or SNRI to improve their mood and do we see an improvement on the depression scale? So the secondary endpoint are quite interesting and quite important. And I think it's a little bit related, if you'll allow me, to the previous question. As you know in this trial, we have the possibility to split the population or the patient population included in the trial into patients with insomnia complaints and patients without insomnia complaints. So clearly, this secondary endpoint will be extremely important to understand what is the link between the direct effect we have seen of our molecule and mood and what is the added value or influence of insomnia on the results.

Now in terms of how it is differentiated. So first of all, I think it is differentiated, and if I can speak, even if it's the data are blinded from me, yes, I mean moving on the recruitment during the complete study, I mean we could really see that this molecule is extremely, extremely well tolerated, yes? And compared to existing therapy strategies in order to bring back to normal-seeming the same patient who is not responding well to existing therapies, what they are usually using, excuse me, is -- are antipsychotics with all the side effects you can think about. So first of all, safety is extremely important. Second, the mechanism of action, I think, is extremely unique, yes, because here, as I think I explained in one of the previous calls, we are really trying to modulate somehow all the consequences of being depressed. So in other words, the stress hormones are regulated or normalized as the autonomic nervous system is normalized or modulated with a molecule like ours and best of my knowledge, I mean, we have no other molecule, which is really working in this way. So if the data are positive when we will have the data, this will be really a complete game changer in the way you can think about treating patients.

And obviously, last but not least, as you know, depressed patients usually when they're coming to see first time their treating physician have complaints about sleep, sleep disorder, yes? So I'm not saying that I mean sleep is the only driver for depression, but I mean it is this kind of warning symptom in order to help the clinician asking themselves, do we face here a depression or purely a sleep disorder? So again, by having a drug having a positive effect in terms of sleep, not only in terms of insomnia, but also in preserving the sleep physiology. So preserving deep sleep, for example, is extremely important. So all this data will be extremely important moving forward, obviously, but are definitely giving a specific and unique profile to our molecule.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [15]

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Very good. And then maybe another question. Could you provide any thoughts on how expenses may change over the course of the year, or if they'd be relatively consistent? I mean I guess with the idea that you'll have a few trials wrapping up around the middle of the year, but for those trials that seltorexant are under, are you in trial development joint with Janssen?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [16]

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Obviously, it's difficult to predict, but, Geoff, please jump in if you want to give more color, yes? But it is true that, I mean, to run this -- all these trials is quite expensive and moving forward, it will come a time where, as we already discussed, we will have to analyze the data. We will have to design the Phase III program and here, in terms of clinical study costs, things will definitely go probably a little bit down. But on the other hand, as I've already mentioned, we are really working the complete package for seltor -- for roluperidone, excuse me, and we are currently running some drug-drug interaction studies. We are completing the clean pharm package and obviously there is a lot of CMC work going on.

So all in all, I have not a good answer to give you, but I think the costs moving forward will be kept under control as we always have done, but being able, nevertheless, to achieve all which we want to achieve. But I don't know, Geoff, if you want to add something to what I'm saying here?

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Geoffrey Robin Race, Minerva Neurosciences, Inc. - Executive VP, CFO & Chief Business Officer [17]

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Just 10 seconds, Joel. Thank you very much for the question. Obviously, we started this year with $88 million in cash. Burn rate will be slightly down on last year. Obviously, the first half of this year, we're running multiple studies, but we'll see those tail off towards the end of the year. Obviously, the 9-month extension period will continue to run in the roluperidone study. But probably similar burn rate to last year and next year that will fall slightly. I guided in the earnings call earlier to a cash runway taking us to early '21 and basically they're the assumptions that underpin that current forecast.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [18]

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Great. And maybe one last question on the timing for roluperidone. I see in the most recent slide deck that you're guiding towards a launch in 2021 or 2022. But that was before the delay that was announced today. Does the delay announced today in enrollment affect the potential launch timing for 2021 or 2022? Then could you also talk about maybe what the important factors are that affect whether the potential launch could happen in 2021 or 2022?

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [19]

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So I can take this question, Joel. So definitely, I don't think that this has any impact on the timing for very simple reason is that, first of all, I mean, we are extremely well advanced with our NDA preparation that we had really integrated some buffer here, yes, because I think this is what you have to do. And I mean in terms of CMC, in terms of scale-up, in terms of preparation of launch, the things are going extremely smoothly, yes? So definitely, there's no impact on the 2021/22 time lines. But I don't know, Rick, do you want to add something about -- or what you are doing currently in terms of being ready?

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Richard Russell, Minerva Neurosciences, Inc. - President [20]

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Yes. We'll definitely be ready to launch very, very soon after approval and I think really when you look at that time line that we've previously communicated, really the biggest ring factor between the end of '21 and early '22 is how long it takes for the agency to complete their review of the file. But we will be ready to go commercially upon approval.

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Operator [21]

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And that concludes our question-and-answer session for today. I'd like to turn the conference back over to Dr. Rémy Luthringer for closing comments.

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Rémy Luthringer, Minerva Neurosciences, Inc. - Executive Chairman & CEO [22]

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Yes. Thank you all for your participation in today's call. I'm really looking forward to update you very, very soon about progress of all the products we are currently developing for unmet medical needs in patients suffering from neuropsychiatric disorders. Thank you, again, and have a nice day. Bye-bye.

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Operator [23]

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Ladies and gentlemen, this concludes today's presentation. Thank you, once again, for your participation, and you may now disconnect. Everyone, have a great day.